BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 10446485 · Received August 24, 2020

    Report

    Report Number
    6000034-2020-02201
    Event Type
    Injury
    Date Received
    August 24, 2020
    Date of Event
    January 1, 2019
    Report Date
    August 3, 2020
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON AUGUST 25, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF FIXTURE IN 2019, SEVERAL WEEKS AFTER INITIAL IMPLANTATION SURGERY. REIMPLANTATION WITH A NEW DEVICE ON THE CONTRALATERAL SIDE IS PLANNED, BUT HAS NOT YET OCCURRED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905358 ASKU COCHLEAR BAHA CONNECT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention